FDA 510(k) Applications for Medical Device:
Block, Beam-Shaping, Radiation Therapy
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K071077 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K111759 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K123015 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K132236 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K071078 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K091911 | .DECIMAL, INC. |
121 CENTRAL PARK PLACE | SANFORD | FL | 32771 |
| K001163 | 3D LINE USA, INC. |
2807 OLD COURT RD. | BALTIMORE | MD | 21208 |
| K214093 | 3D Systems |
5381 S Alkire Circle | Littleton | CO | 80127 |
| K973953 | AKTINA MEDICAL PHYSICS CORP. |
360 NORTH ROUTE 9W | CONGERS | NY | 10920 |
| K974239 | AKTINA MEDICAL PHYSICS CORP. |
360 NORTH ROUTE 9W | CONGERS | NY | 10920 |
| K010172 | ARPLAY MEDICAL S.A. |
1, ROUTE DE CITEAUX | IZEURE, COTE D'OR | 21110 | |
| K972016 | C.L. MCINTOSH & ASSOC., INC. |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K000137 | COMPUTERIZED MEDICAL SYSTEMS, INC. |
1195 CORPORATE LAKE DR. | ST. LOUIS | MO | 63132-1716 |
| K123893 | CURA MEDICAL TECHNOLOGIES, LLC |
23 RANCHO CIRCLE | LAKE FOREST | CA | 92630 |
| K131150 | CURA MEDICAL TECHNOLOGIES, LLC |
23 RANCHO CIRCLE | LAKE FOREST | CA | 92630 |
| K040553 | DIREX SYSTEMS CORP. |
11 MERCER RD. | NATICK | MA | 01760 |
| K111676 | Elekta Limited |
LINAC HOUSE, FLEMING WAY | CRAWLEY | RH10 9RR | |
| K970303 | GENERAL ELECTRIC CO. |
P.O. BOX 414 | MILWAUKEE | WI | 53201 |
| K052383 | INNOCURE, LLC |
201 E. SOUTHERN AVE. | TEMPE | AZ | 85282-5133 |
| K981992 | MED-TEC,INC. |
1401 8TH ST. S.E. | ORANGE CITY | IA | 51041 |
| K013875 | MED-TEC,INC. |
1401 8TH ST. S.E. | ORANGE CITY | IA | 51041 |
| K971001 | MEDIZINTECHNIK, GMBH |
12300 TWINBROOK PARKWAY, | ROCKVILLE | MD | 20852 |
| K011816 | MRC SYSTEMS GMBH |
HANS-BUNTE-STR. 10 | HEIDELBERG | 69123 | |
| K030609 | MRC SYSTEMS GMBH |
HANS-BUNTE-STR. 10 | HEIDELBERG | D-69123 | |
| K091403 | ONCOLOGY TECH, LLC |
5608 BUSINESS PARK | SAN ANTONIO | TX | 78218 |
| K021987 | S&S PAR SCIENTIFIC |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K990491 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVE. SOUTH | ISELIN | NJ | 08830 |
| K032790 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. | CONCORD | CA | 94520 |
| K961902 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. | CONCORD | CA | 94520 |
| K954248 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
4040 NELSON AVE. | CONCORD | CA | 94520 |
| K040804 | SOUTHEASTERN RADIATION PRODUCTS, INC. |
2651 N. DESIGN COURT | SANFORD | FL | 32773 |
| K000349 | STRYKER LEIBINGER |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K062781 | SYMTIUM CORPORATION |
11503 JONES MALTSBERGER | SAN ANTONIO | TX | 78216 |
| K060187 | TOPSLANE INTERNATIONAL, LLC |
15375 ROOSEVELT BLVD. | CLEARWATER | FL | 33760 |
| K222639 | VHA DEAN |
810 Vermont Ave NW | Washington | DC | 20420 |
| K090417 | XOFT, INC. |
345 POTRERO AVE. | SUNNYVALE | CA | 94085 |
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